Legal: No Exception?

Doomsayers have recently painted a grim picture of the future prospects for biotech R&D. Although biotech research has exploded in the past three decades, a parallel explosion seems, at first glance, to threaten those scientific achievements. An exponential increase in patenting activity threatens to put roadblocks in the path of corporate, academic, and governmental research.

Patents provide incentive for biomedical innovation. Pharmaceutical companies, universities, economists, and others worry that drug and biomedical discoveries will be thwarted by the growing cost of access to patented research tools such as databases, peptides, biomarkers, and bioassays. And a legal avenue long used to circumvent these costs—the "experimental use defense"—is no longer an easy fallback.

While it's true that recent judicial rulings relating to the experimental use defense have changed the landscape somewhat, savvy researchers, both in the private sector and in academia, are learning how to navigate these changes and still get the job done.

Changes in Experimental Use
The United States has two legal provisions that permit experimental use of a patented resource as a tool in the development of new drugs, therapies, diagnostic methods or other therapeutic products. The first, the common law exception, was created almost 200 years ago to allow a patented invention to be used in the pursuit of intellectual curiosity, without any commercial purpose. The common law exception traditionally has been quite limited in scope—mainly benefiting universities.

Indeed, it appears that even universities will have a hard time making use of the common law exception in the wake of a 2003 case: Madey v. Duke University. Madey, an expert in lasers, moved his laboratory from Stanford to Duke in 1989. When he left Duke in 1998, he left behind equipment on which he held patents.

He later sued, arguing that in continuing to use the equipment, Duke was violating his patents. While research conducted at the university was not directly linked to a for-profit enterprise, the court held that it was furthering the "legitimate business" of the institution. By enlightening the students and faculty involved, and increasing the status of Duke, the use went beyond mere intellectual curiosity. As a result, Duke could not claim the common law defense and was infringing on Madey's patents.

That ruling withstood an appeal—and the standard for the common law exception was elevated even for universities, its last beneficiaries. Some fear that Madey v. Duke may have a chilling effect on academic research, which often is at the heart of new developments in the for-profit world.

The second provision, often referred to as the "safe harbor" exemption, was created as part of the 1984 Hatch-Waxman Act. This defense allows experimentation with a patented invention if the use is "reasonably related" to obtaining FDA approval, and was designed primarily to speed generic medicines to market by enabling their manufacturers to conduct experiments with a compound before the originator company's patent on the compound expires.

As this issue went to press, the US Supreme Court heard a case involving Integra Lifesciences and Merck KgaA, which will determine whether the safe harbor does in fact cover pre-clinical use of a patented technology to develop or identify new drugs. This case heightens concern about how such changes would affect the use and development of new biotech discoveries.

The case involves Integra's patents on certain peptides that promote cell adhesion, and that may help wounds heal faster and improve the biocompatibility of prosthetic devices. David Cheresh, a scientist at Scripps Research Institute, discovered that the mechanism that encourages cell adhesion also can be used to inhibit angiogenesis. With the backing of Merck, Cheresh worked on identifying potential drug candidates—which included compounds derived from one of Integra's patented peptides.